Cosette Pharmaceuticals Announces FDA Approval of EVOXAC® (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval
Cosette Pharmaceuticals, a private specialty pharma company backed by Avista Healthcare Partners and funds managed by Hamilton Lane (Nasdaq: HLNE), received FDA approval for EVOXAC (cevimeline HCl) oral solution to treat dry mouth in adults with Sjögren's disease. This is Cosette's first NDA approval, achieved via a streamlined pathway relying on existing safety and efficacy data for its already-approved EVOXAC capsules, avoiding a full clinical program. The product is expected to be commercially available in the U.S. by the end of 2026.
Key figures
- Drug Name
- EVOXAC (cevimeline HCl) oral solution
- Cosette employees
- 350+
- Sjogrens us patients
- approximately four million
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